Medtech approvals: FDA releases August 2015 PMAs

The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015:
Summary of PMA Originals &Supplements Approved
Originals: 2
Supplements: 70
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 28
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 569
Total Active: 422
Total On Hold: 147
Summary of All PMA Submissions
Originals: 5
Supplements: 90
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 70
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 229.0
FDA Time: 130.3 Days
MFR Time: 98.7 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, &ZIP
DEVICE DESCRIPTION / INDICATIONS
P140008
8/5/15
Orbera™ Intragastric Balloon
Apollo Endosurgery, Inc.
Austin, TX
78746
Approval for the Orbera Intragastric Balloon. The ORBERA™ Intragastric Balloon System is indicated for use as an adjunct to weight reduction for adults with obesity with Body Mass Index (BMI) of ≥ 30 and ≤ 40 kg/m2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. ORBERA™ is indicated for adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and beha...

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PMID: 31118341 [PubMed - in process]

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Abstract
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CONCLUSION: Hearing performance was significantly better with ADHEAR under all test conditions except those where maximum perception was already achieved without ADHEAR.
PMID: 31119336 [PubMed - as supplied by publisher]

Authors: Daida H, Dohi T, Fukushima Y, Ohmura H, Miyauchi K
Abstract
Enormous effort has been put into the prevention of atherosclerosis through risk modification, especially with lipid-lowering therapies. Regression, that is, the reversal of the atherosclerosis process, has long been a goal of atherosclerosis research among basic and clinical investigators. Intravascular ultrasound (IVUS) was developed in the 1990s as an intracoronary imaging technique to observe the details of the vessel walls and to measure the vessel lumen and plaque area with high reproducibility. Compared with the coronary angiogram, IVUS pro...

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